Senior Quality Systems Specialist I

Overview

Position Summary:

Responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. The focus of the position is to assist in maintaining and monitoring key Quality Systems. Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key project support under the supervision of the Quality Systems Manager.

This position is located out of our Bedford, MA facilities and the anticipated work set up is 4 days onsite and 1 day remote.

Responsibilities

Key Accountabilities

Essential Functions: